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临床试验/NCT04125589
NCT04125589已完成不适用

Understanding The Effects of Acute Stressors and Negative Emotion on Eating Behavior in Binge-Eating Disorder: The Role of Stressor-Induced Changes in Reward and Cognitive Control

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2019年12月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
1
主要终点
Decision-making behavior (actual decisions)

研究概览

简要总结

The investigators are doing a study of women with and without binge-eating disorder to learn more about what happens when people engage in everyday decision-making activities. The investigators are interested in learning more about brain activity during everyday decision-making and how everyday decision-making relates to a variety of daily experiences. Examples of everyday decisions include deciding which product to buy, deciding what to eat for a snack, and deciding how to spend free time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion Criteria for All Participants:
  • Normal or corrected to normal vision and hearing
  • Verbal and written fluency in English
  • Right-handed
  • Body mass index of 20-35 kg/m^2
  • Additional Inclusion Criteria for Participants with Binge-Eating Disorder:
  • DSM-5 binge-eating disorder

排除标准

  • Exclusion Criteria for All Participants:
  • Impaired cognition or other neurological/cognitive problems
  • Contraindications to MRI (e.g., certain metal implants, claustrophobia)
  • Currently/recently/potentially pregnant, seeking to become pregnant in the near future, or breastfeeding
  • Serious and/or unstable medical diseases and conditions, and certain other medical diseases and conditions
  • Recent low weight
  • Certain medications (e.g., insulin)
  • Current/recent frequent recreational drug use, or history of frequent recreational drug use in early adolescence
  • Extreme dietary limitations (e.g., veganism), pervasive food allergies, or limited exposure to popular snack foods
  • Current/recent suicidality
  • Current/recent changes in treatment for mental illness
  • Study-relevant research experience
  • Additional Exclusion Criteria for Comparison Participants:
  • Personal history of eating disorders or recurrent binge eating
  • Personal history of any other mental illness, including serious substance use problems
  • First-degree relative with current or past eating or psychotic disorder
  • Significant recent change in weight
  • Additional Exclusion Criteria for Participants with Binge-Eating Disorder:
  • Severe mental illness (e.g., psychotic disorder, severe agoraphobia)
  • Certain other current/recent mental illness, including severe substance use problems, that would limit study participation or safety
  • Recent anorexia nervosa spectrum disorder, avoidant-restrictive food intake disorder, or bulimia nervosa spectrum disorder

研究组 & 干预措施

Speaking Activity and Talking Activity

Experimental

Participants will engage in a speaking activity first and a talking activity second.

干预措施: Talking Activity (Behavioral)

Speaking Activity and Talking Activity

Experimental

Participants will engage in a speaking activity first and a talking activity second.

干预措施: Speaking Activity (Behavioral)

Talking Activity and Speaking Activity

Experimental

Participants will engage in a talking activity first and a speaking activity second.

干预措施: Speaking Activity (Behavioral)

Talking Activity and Speaking Activity

Experimental

Participants will engage in a talking activity first and a speaking activity second.

干预措施: Talking Activity (Behavioral)

结局指标

主要结局

Decision-making behavior (actual decisions)

时间窗: Up to 1 hour post-intervention

Decisions (i.e., percent of goal-inconsistent decisions from challenge trials)

Decision-related BOLD activation (reward regions-of-interest)

时间窗: Up to 1 hour post-intervention

Percent change in blood oxygen level-dependent (BOLD) signal in response to decision making in regions involved in reward (e.g., nucleus accumbens, insula)

Decision-related BOLD activation (executive function regions-of-interest)

时间窗: Up to 1 hour post-intervention

Percent change in blood oxygen level-dependent (BOLD) signal in response to decision making in regions involved in executive function (e.g., dorsolateral prefrontal cortex, inferior frontal gyrus)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristin Nicole Javaras

Assistant Psychologist, Division of Women's Mental Health, McLean Hospital; Assistant Professor of Psychology, Department of Psychiatry, Harvard Medical School

Mclean Hospital

研究点 (1)

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